MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136506000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Depression (2361)

Event Date 12/02/2011

Event Type  Injury  

Manufacturer Narrative

No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Oct 6, 2017: litigation record received. Litigation alleges pain, discomfort, soreness, friction and wear causing toxic metal ions and particles.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN ; UK
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 6998838
• MDR Text Key: 104471872
• Report Number: 1818910-2017-28017
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/30/2014
• Device Catalogue Number: 136506000
• Device Lot Number: 2820689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown